Consent, Waivers & PICFS

Participant Information & Consent Forms (PICFs)

One of the most important ethical rules governing research on humans is that participants must give their informed consent before taking part in a study or a request is made to waive the requirement for consent.

The essential elements of informed consent include:

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the participant's participation, a description of the procedures to be followed, and identification of any procedures which are experimental

A description of any reasonably foreseeable risks or discomforts to the participant

A description of any benefits to the participant or to others which may reasonably be expected from the research

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant

A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained

An explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained

An explanation of whom to contact for answers to pertinent questions about the research and research participants' rights, and whom to contact in the event of a research-related injury to the participant

A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

It is essential that consent forms be written in plain language that research participants can understand. In addition participants should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence. At Barwon Health, we expect the PICF is included in the patient’s medical history.

Please add the following statement regarding the site specific contact for complaints:

If you have any complaints about any aspect of the project, the way it is being conducted, or any questions about being a research participant in general, then you may contact Dr Giuliana Fuscaldo, Manager, REGI Unit, Ph: (03) 4215 3372, email: gfusca@barwonhealth.org.au

For more detailed information about different forms of consent, including opt in and opt out, implied consent, and waivers of consent, please view the guidelines for 'Seeking Consent and Waiver of Consent' on the Guidelines and advice webpage.

Privacy, Legislation and Applications for Waiver of Consent

Background

The Guidelines under Section 95 of the Privacy Act 1988 (s95 Guidelines) provide a framework for the conduct of medical research using information held or collected by agencies where personal information needs to be used and where it is not practicable to obtain the individual's consent.

In these situations, an agency may collect, use, or disclose records containing personal information for medical research purposes without breaching the Privacy Act if the proposed medical research has been approved by a properly constituted Human Research Ethics Committee (HREC) in accordance with the s95 Guidelines.

The NHMRC has developed a form that provides a template for researchers and HRECs to satisfy data custodians that the s95 Guidelines have been appropriately applied and provide evidence that the HREC has the necessary qualifications and/or experience to consider privacy issues.

When do I need to apply for a waiver?

As a general rule of thumb, consent or a waiver of consent is not required where a study involves the use of data derived from routine clinical practices for the purposes of quality assurance. An application for a waiver of consent should not be confused with the 'application for exemption of ethics committee review', which is only relevant for negligible risk projects using de-identified data, or projects which have prior approval from other institutional HRECs.

The Office of the Federal Privacy Commissioner's Guidelines on Privacy in the Private Health Sector states that an organisation's quality assurance or clinical audit activities may constitute secondary activities that are directly related to the purpose for which consent was given, and therefore that consent may not be required for these types of activities.

More specifically, the access or use of data (both de-identified and identified) for the purpose of research does not require consent or a waiver when:

The data to be accessed or used has already been collected as a routine part of practice; or

The data will be collected as a matter of routine business (e.g. clinical care, training, planning, or management of the health service); or

The data that will be used for the purpose of research, audit or quality improvement or other research activities are directly related to the primary purpose for which the data was/will be collected

However, a waiver is required when access to data is sought by:

A person that would not normally have access to the data as part of their employment with Barwon Health for that purpose; or

The purpose of use and access to the data is not related to the original purpose of collection.

For more detailed information about different forms of consent including opt in and opt out, implied consent, and waivers of consent, please view the Guidelines for 'Seeking Consent and Waiver of Consent' on the Guidelines and advice webpage.

If you are still unsure whether a waiver of consent is required for your research, please complete the Waiver of Consent Checklist found on the Forms webpage.

How to Apply for a Waiver of Consent

The documents below have been developed by the NHMRC to assist researchers and HRECs with the appropriate application of the s95 and s95A Guidelines.

Under paragraph 2.3 of the s95 Guidelines, when research may involve a breach of one or more APPs:

the proposal for that research to be submitted to a HREC must contain a reference to the APP(s); and

must also state reasons for believing that the public interest in the research outweighs, to a substantial degree, the public interest in complying with the APP(s)

Researchers should complete the waiver template, which identifies the APPs that may be breached by the proposed research, and should provide reasons to justify the breach. The completed and signed waiver should be submitted to the REGI Unit along with all other application documents via email to regi@barwonhealth.org.au.

Completing a Waiver Template

Part A - to be completed by the responsible researcher

Part B - to be completed by two Barwon Health HREC Members

Parts C & D - to be completed by the approving HREC Chairperson

Part E - both the researcher and the Chairperson are required to sign the declaration at Part E

Please note: Researchers should refer to the APP Quick Reference Tool or the Privacy Fact Sheet to assist in completing the waiver template.

Reporting Waivers of Consent

For the purposes of transparency and accountability supporting the desire to instil public faith in research, research institutions are required to make publicly available a summary of all the research projects for which consent has been waived, in accordance with the National Statement, Section 2.3.9 - 2.3.12.

The Barwon Health HREC waived the requirement for consent for the collection, use and/or disclosure of personal information in medical research or personal health information, for the projects listed here.

In reaching the decision to waive the requirement for consent, the HREC considered and applied Sections 2.3.6 and 2.3.7 of the National Statement, and one or more of the following:

a) Statutory Guidelines on research issued under Section 22 of the Health Records Act 2001 (VIC)orb) Guidelines approved under Section 95A of the Privacy Act 1988 (Commonwealth)orc) Guidelines approved under Section 95 of the Privacy Act 1988 (Commonwealth), as applicable.